The European Union (EU) is now pushing for stricter border measures for IPR enforcements in the EU-India Free Trade Agreement (FTA) negotiations, which will impact access to generic medicines.
Stringent EC Customs Regulations that allow European customs officials to detain generic medicines at transit points have been in place since 2003. This has resulted in detainment of many legitimate generic drug shipment of antibiotics and AIDS drugs, which were only in transit through the EU (going from one developing country to patients in other developing countries), on the grounds that they infringe European intellectual property law (patents and trademark). Later, it turned out that the medicines were not in violation of IP laws of the sending and recipient countries involved, but were legitimately produced by mainly Indian generic companies and were being imported by Brazil, Peru, Colombia, Mexico, Nigeria and other developing countries at affordable prices. Though EU is now willing to amend its custom regulation, after being taken by India to WTO dispute settlement court, for unlawful seizure of medicines in transit on grounds of patent infringement, it is now pushing for having this clause in EU-India Free Trade Agreement (FTA) negotiations which, if accepted, will force Indian law makers to have custom/border measures that may lead to detention and even destruction of generic drugs at the port being imported or exported to other countries.

In its FTA negotiations with India, which started in 2007 and hope to be completed by 2011, the EU has put forward a proposal on border measures (which is based on existing EU customs regulations) in the articles that cover intellectual property enforcement. This provision, if accepted by India, can affect the distribution and availability of affordable generic medicines across the developing world. The goods mentioned in it, which will attract border detention and seizure measures, include pharmaceutical products that infringe intellectual property rights - the definition of which covers patents and all trademarks disputes.
The measures would apply to goods that are being imported/ exported by India, or are in transit via Indian ports/airports. Europe appears to want that the FTA forces Indian lawmakers to frame customs/border measures similar to its customs regulations authorizing companies to lodge complaints with Indian customs authorities to detain, or suspend the release of, or even destroy shipments of generic medicines on the basis of mere allegations of intellectual property infringement (trademark disputes/patents) without judicial review or even notification to the generic producer.
Let us hope that the provisions in the EU-India FTA on border measures would be influenced by the
outcome of the WTO Dispute and amended accordingly.

Meanwhile we need to become aware of some of the safeguards to protect access to generic medicines that may be under consideration of India-EU FTA. The following two specially merit serious consideration:
(i) Both patents and trademark infringement disputes should be excluded from the in transit border measures proposed in the EU-India FTA draft text.
A safeguard limited to only excluding patents from the border measures is unlikely to prevent the detention of generic medicines on grounds of commercial trademark infringement. Detentions on grounds of trademark infringement can also disrupt supply of medicines. Besides patents, trademark infringement disputes, that companies may have with generic competitors over similar named/ shaped medicines or packaging should not be considered as willful trademark counterfeiting and should be excluded from enforcement measures like seizures and detention at the borders.
One such illegal customs seizure of a legitimate consignment of an essential antibiotic occurred in June 2009, when EU custom officials at Frankfurt detained a consignment of generic drug amoxicillin on mistaken grounds of trademark infringement, confusing the international non-proprietary name (INN) of the medicine with the brand name ‘Amoxil’ owned by GlaxoSmithKline (GSK). The consignment was released only once GSK confirmed that there was no trademark infringement as amoxicillin is an international non-proprietary name (INN) in the public domain and as such is not the trademark of GSK.

(ii) Goods in Transit as well as Exports—both should be excluded from border measures
Recognizing the impact of the EU seizures of medicines in transit, India is likely to seek a specific safeguard that goods in transit via its territory or European territory are not subject to any enforcement procedures relating to infringement of Intellectual Property Rights (IPR). But this alone is not enough. It may not be wise for India to concede to EU demand of including exports in border measures. While EU ports/airports might be a key transit point for medicine consignments, generic medicines are also regularly exported from Indian ports/airports, as India is a major producer and supplier of essential medicines to developing countries.
If exports are not excluded from border measures, multinational pharmaceutical companies could lodge complaints with local customs authorities to seize shipments of generic medicines meant for exports on the basis of IP infringement allegations. Also, if India accepts that border measures for IP enforcement can be applied to export consignments meant for other countries then it will limit the policy space of importing countries to apply their own IP laws. IP such as patents and trademarks are territorial and it is for the importing country to decide if an import will breach national IP laws.

Increased enforcement of IP laws has already been used as a tool by European pharmaceutical companies within EU, to limit the legitimate trade in high quality generic medicines between developing countries. Extending IP enforcement rules related to border measures to third world countries through FTAs widens the opportunities to disrupt the trade in generic medicines. Such measures also effectively provides public resources for the enforcement of private IP rights of European pharmaceutical companies in countries like Mexico, India, Korea. The customs officials in these third countries become the IP police at the borders for pharmaceutical companies.

The dangers of this approach are clear. The EU is using its bilateral FTAs with countries like India to impose regulations that allow the use of IP allegations in the area of pharmaceuticals to stop trade in legitimate generic medicines. This is clearly a tactic by the big pharmaceutical companies to deter the generic producers in the developing countries from producing cheaper and affordable drugs.

But let us end on a cheerful note—even if it be like a drop of honey in this murky business of money (read profit). India formally announced at the recent UN High Level Meeting on HIV and AIDS that it will not accept data exclusivity, a provision harmful to access to affordable medicines, as part of theFTA with the EU. This is an important victory for the global mobilization against the potential negative impact of the FTA on access to medicines. By delaying the registration of generic versions of a medicine by up to ten years, data exclusivity would effectively have given a backdoor monopoly status to companies, even for drugs that do not deserve a patent under India’s law.

“MSF (Medicins Sans Frontieres)and other treatment providers depend on a sustainable flow of affordable generics from India to treat people across the developing world. Saying ‘no’ to data exclusivity will reach far beyond India’s borders in terms of ensuring access to affordable medicines in developing countries”, said Dr Tido von Schoen-Angerer, Executive Director of MSF’s Campaign for Access to Essential Medicines. “This is a big victory, but we’re not letting up until we see all the potentially harmful policies off the table”.
So be it.

Shobha Shukla - CNS(The author is the Editor of Citizen News Service (CNS). She is a J2J Fellow of National Press Foundation (NPF) USA. She is also the Director of CNS Gender Initiative and CNS Diabetes Media Initiative (CNS-DMI). She has worked earlier with State Planning Institute, UP. Email: shobha@citizen-news.org, website: http://www.citizen-news.org)